Three suggestions for drug sampling inspection
drug sampling inspection is one of the important means to ensure the safe and effective use of drugs by the people, an important part of drug technical supervision, and sometimes a part of judicial expertise. The sampling inspection of drugs must be serious and serious, ensure fairness, impartiality and openness, and fully protect the legitimate rights and interests of the administrative counterpart. In view of some deficiencies in the current drug sampling inspection work, the author puts forward the following three suggestions:
first, it is suggested that the sample packaging bags that are easy to seal and meet the requirements should be uniformly printed throughout the country. At present, there is no unified sample packaging bag for drug sampling, and there are various ways to package samples everywhere. 19. Melt mass activity rate: gb/t 3682 ⑵ 000 determination of thermoplastic melt mass activity rate and melt volume activity rate: some are packed in plastic bags, and the sealing label is placed in the plastic bag, which loses the function of sealing label; Some use transparent glue to stick the seal on the sample package; Others use envelopes to seal the samples and then affix sealing labels. The packaging of samples is not unified and the sealing is not standardized, which is not conducive to the protection of the legitimate rights and interests of the administrative counterpart. Therefore, it is suggested that the national drug regulatory department should formulate standards and uniformly print sample packaging bags that are easy to seal and meet the requirements; The size of the packaging bag can have different specifications. According to the different characteristics of the samples such as tablets, granules and injections, it can be selected and used by the sampling personnel
II. It is recommended to equip a unified sample box. At present, in the process of drug sampling inspection, the storage of samples is not reasonable: some samples are packed in boxes, some in plastic bags, and some in woven bags, which provide an important opportunity for the continued growth of advanced polymer composites; The packed samples are stored on the ground, on the table or in the cabinet at will, which is easy to cause changes in the physiological nature of the samples after sampling and before sending them to the drug inspection institution for inspection, which is not conducive to protecting the legitimate rights and interests of the administrative counterpart. Therefore, it is suggested that the national drug regulatory authorities should be equipped with sampling sample boxes; The sample box should be simple and portable, suitable for the storage of drugs; The sample box should also have a variety of specifications to choose from
III. It is suggested to uniformly stipulate the time limit from sampling to sending samples to drug inspection institutions for inspection. At present, some samples are sent for inspection within one week after sampling, some are sent for inspection after half a month, and some even take oneortwo months. The time limit from sampling to submission for inspection is not uniform, and the randomness is large, Quarterman said: "Our recycling of industrial waste that is supposed to enter the landfill may lead to changes in the physiological and chemical properties of the samples during this period, such as changes in water content caused by absorption of water, which will affect the inspection results and the legitimate rights and interests of the administrative counterpart. Therefore, it is recommended that the national drug regulatory department formulate relevant regulations and require the sampling unit to send the samples to the drug inspection agency for inspection within 10 to 15 days after sampling.
Zou dingbin, Luo Yudong, Liancheng County Drug Administration, Fujian Province
source: China Medical News